Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no hazard identified

Marine water

Hazard assessment conclusion:
no hazard identified

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
100 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
no hazard identified

Sediment (marine water)

Hazard assessment conclusion:
no hazard identified

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Based on the available data the substance leads to the classification R53 May cause long-term adverse effects in the aquatic environment according to Directive 67/548/EEC. The substance is poorly soluble in water; it does not fulfil the criteria for ready biodegradability and log Kow estimations yields to values > 10, independent of the discussion on bioaccumulation properties of the substance.

This criterion applies to substances unless there exist additional scientific evidence concerning degradation and/or toxicity sufficient to provide an adequate assurance that neither the substance nor its degradation products will constitute a potential long-term and/or delayed danger to the aquatic environment.

Additional scientific evidence is provided by a study performed to assess the effects of the substance on the reproductive output of parthenogenetic Daphnia magna under semi static conditions. The study was conducted in accordance with Council Regulation (EC) No 440/2008, Method C.20 'Daphnia magna Reproduction Test'' (2008), which equals in all relevant parts to the OECD Test guideline 211 (Daphnia magna Reproduction Test; adopted: Oct. 03, 2008). No toxic effects on reproduction and mortality against Daphnia were observed up to three-fold of the water solubility under exposure conditions. This result clear indicate an absence of chronic toxicity effects at the solubility limit, as the no-observed effect concentration is greater than the solubility limit determined in this study.

According to Regulation EC1272/2008 including 2nd ATP 2011 (GHS), the available data for the substance leads to the classification Chronic Cat 4.

This category includes poorly soluble substances for which no acute toxicity is recorded at levels up to the water solubility, and which are not rapidly degradable and a log Kow ≥ 4, unless other scientific evidence exists showing classification to be unnecessary. Such evidence includes chronic toxicity NOECs > water solubility or > 1 mg/l, other evidence of rapid degradation in the environment. Scientific evidence is provided by a chronic toxicity test towards Daphnia magna, resulting in a NOEC > 10 mg/l, which is three-fold of the water solubility, and a NOEC > 100 mg/l (nominal), obtained in an algae toxicity test. These results clear indicate an absence of chronic toxicity effects at the solubility limit.

In conclusion, a hazardous potential of the substance can be ruled out and hence no classification according to both and Directive 67/548/EEC and GHS (Regulation EC 1272/2008) is required.